BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 3/10ML 6MM (15/64") 31G

    MDR report key: 15166022 · Received August 4, 2022

    Report

    Report Number
    1920898-2022-00512
    Event Type
    Malfunction
    Date Received
    August 4, 2022
    Date of Event
    July 5, 2022
    Report Date
    August 10, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249107
    PMA / PMN Number
    K212499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE, LOT #: 1144160. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2026. DEVICE MANUFACTURE DATE: 24-MAY-2021, MEDICAL DEVICE LOT #: 1242719, MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2026, DEVICE MANUFACTURE DATE: 30-AUG-2021. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED IMAGES OF TWO SEPARATE 0.3ML SYRINGES. NO LOT IDENTIFICATION WAS AVAILABLE FOR EITHER SYRINGE. ONE SYRINGE SHOWS A BEAD OF A CLEAR LIQUID TOWARD THE TIP OF THE SYRINGE ON ITS NEEDLE. THE OTHER SYRINGE HAS HAD THE THUMBPRESS ON THE PROXIMAL END OF THE PLUNGER ROD BREAK OFF. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCHS 1144160 AND # 1242719 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. BASED ON THE SAMPLES RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF FOREIGN MATTER. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THREE HUNDRED TIMES THAT PRIOR TO USING THE BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 3/10ML 6MM (15/64") 31G U-100 1/2 UNIT 100COUNT, FOREIGN MATTER INSIDE THE BARREL WAS OBSERVED. BEFORE USE, THE CUSTOMER DISCOVERED LIQUIDS INSIDE OF THE BARREL AND THE LIQUID COMES OUT WHEN PLUNGER IS PRESSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THREE HUNDRED TIMES THAT PRIOR TO USING THE BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 3/10ML 6MM (15/64") 31G U-100 1/2 UNIT 100COUNT, FOREIGN MATTER INSIDE THE BARREL WAS OBSERVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BEFORE USE, THE CUSTOMER DISCOVERED LIQUIDS INSIDE OF THE BARREL AND THE LIQUID COMES OUT WHEN PLUNGER IS PRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1945802 BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 3/10ML 6MM (15/64") 31G PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324910 SEE H.10. 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown